The system and manufacturing process disclosed herein, in general, relates to nanobiopharmaceutics. More particularly, the system and manufacturing process disclosed herein relates to nano-encapsulated drugs, their controlled and/or scheduled delivery method, manufacturing process, and processing of nanosized, delivery controlled encapsulated drugs.
Traditional medicine administered orally may have a slower and less complete absorption than medicine administered using parenteral (non-oral) routes. Dissolution of solid formulations (e.g., tablets) must occur first. The drug must survive exposure to stomach acid and this route of administration is subject to first pass effect (metabolism of a significant amount of the drug in gut wall and liver), before it reaches the systemic circulation where it can take effect.
Even if it reaches the systemic circulation, the route of the drug is completely random. It may flow around and be expelled from the body without performing its job.
Because it is hard for the drug to find its desired target, a good amount of the drug is wasted, and a large amount of the medicine must be administrated, increasing toxicity in the body and causing unnecessary medicine waste. More damaging is that, by circulating throughout the body looking for a target, and by increasing the toxicity level of the body, these traditional medicines kill both good cells and bad cells.
In addition, the traditional drugs/medicines are expelled out of the body in a very short time period, which is why some medicines need to be taken multiple times a day for several days. An example is Amoxicillin, which may need to be taken every 6 hours per day, 7 days per treatment session.
In summary, traditional drugs have low effectiveness and efficiency, they may require repeated administration, they cause high levels of body toxicity, and they are expensive.
One of the challenges of pharmaceutical research is to discover tools and methods enabling an effective and efficacious delivery of drugs into tissues or organs where the drugs are needed, and in addition, scheduling delivery of the drugs in a controlled manner.
Nanomedical approach to drug delivery centers on developing nanoscaled particles or molecules to improve drug bioavailability. Bioavailability refers to the presence of drug molecules where they are needed in the body, where they will do most good, and over a desired period of time. More than $65 billion are wasted each year due to poor bioavailability of existing drugs. Thus, drug delivery research focuses on maximizing bioavailability both at specific places in the body and over a period of time.
Protein and peptides exert multiple biological actions in a human body and they have been identified as showing great promise for treatment of various diseases and disorders. These macromolecules are called biopharmaceuticals. Targeted and/or controlled delivery of these biopharmaceuticals using nanomaterials like nanoparticles and dendrimers is an emerging field called nanobiopharmaceutics, and these products are called nanobiopharmaceuticals.
Two forms of nanomedicine that have already been tested in mice and are apparently awaiting human trials is using gold nanoshells to help diagnose and treat cancer, and using liposomes as vaccine adjuvants and as vehicles for drug transport.
It has been seen that drug detoxification is another application for nanomedicine which has shown promising results in rats. A benefit of using nanoscale for medical technologies is that smaller devices are less invasive and can possibly be implanted inside the body. In addition, biochemical reaction times are much shorter. These devices are faster and more sensitive than typical drug delivery.
This strategy took the fashionable name of ‘nanomedicine’ (medical application of nanotechnology), mainly based on the use of lipid-based (liposomes) and polymer-based (nanoparticles or NPs) nano-carriers or metal-based nano-vectors. An example of nano-carriers i.e., super-paramagnetic NPs is currently used in medicine in order to improve quality and specificity of body/cell imaging and diagnostics. These carriers are usually made of gold or iron, comprising a core-shell able to be visualized within the body, thus allowing the physician to obtain better-defined contrast and diagnostic images (http://www.futuremedicine.com/doi/pdf/10.2217/nnm.12.90).
Nano-encapsulated drugs are nanosized packages of drugs that are encapsulated/covered with layer(s) such as liposomes and/or polymer or other biodegradable protective materials, that protect the drugs inside (core drugs) from unfavorable environments and prevent the drug from taking effect until the capsule dissolves. The cover or coating can delay the drug release. Liposomes and other lipid-based nanocapsules cannot be applied to many drugs. Other than liposomes, no other nanocapsules are known to be available due to difficulty of manufacturing them.
Thus, there is a need for development of new medicine, namely nanosized encapsulated medicines, capable of providing time controlled delivery, and which are easier to administer to target area, require fewer administrations, have lower toxicity, and are less expensive overall. Furthermore, since making nanosized encapsulated medicine is very challenging, there is also a need for providing processes, procedures, and systems to make nanosized encapsulated medicines possible.
Further, the process steps of “deposition” and “etching” are well known in the semiconductor industry in integrated circuit fabrication (http://highered.mcgraw-hill.com/sites/dl/free/0073106941/443736/chapter13.pdf and http://www.nature.com/nmatjournal/v2/n1/fig_tab/nmat768_F4.html).
In this disclosure, applicant has applied concepts from the above two well known technologies in the art (nanotechnology and semiconductor) to arrive at a novel method of manufacture of nanosized encapsulated drugs. Since the applicant's disclosure combines two well known technologies in the art, it will be easily implementable by a person with ordinary skill in these arts
The problems and associated solutions presented in this section could be or could have been pursued, but they are not necessarily approaches that have been previously conceived or pursued. Therefore, unless otherwise indicated, it should not be assumed that any of the approaches presented in this section qualify as prior art merely by virtue of their presence in this section of the application.